EPOC Blood Analysis System - Single Use Blood Gas, Electrolyte And Metabolite Test Card
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
EPOC Blood Analysis System - Single Use Blood Gas, Electrolyte And Metabolite Test Card |
03-23056-50 |
CT-1006-00-00 |
EPOC Blood Analysis BGEM Test Cards |
04-23059-50 |
10736515 |
Issue
Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of discrepant high glucose results in samples with glucose results on the lower end of the reportable range (at or below 54 mg/dl) when using the above listed lots of BGEM test cards in conjunction with sensor configuration 41.1 (software version: EPOC Host v3.37.3 and EPOC NXS v4.10.6). the observed maximum bias for the affected lots are detailed in the urgent field safety notice.
Recall start date: June 5, 2023
Additional information
Details
Epocal Inc.
2060 Walkley Road, Ottawa, Ontario, Canada, K1G 3P5
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